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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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This reagent is used for the detection of the Kpa antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007540
In Commercial Distribution

  • 10888234000778 ()
0007540

  • Anti-Kp^a red blood cell grouping IVD, antibody
This reagent is used for the detection of the k antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007537
In Commercial Distribution

  • 10888234000761 ()
0007537

  • Anti-k (KEL002) red blood cell grouping IVD, antibody
This reagent is used for the detection of the s antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007457
In Commercial Distribution

  • 10888234000754 ()
0007457

  • Anti-S [MNS004] red blood cell grouping IVD, antibody
Anti-S reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.
IMMUCOR, INC.
0007454
In Commercial Distribution

  • 10888234000747 ()
0007454

  • Anti-S [MNS003] red blood cell grouping IVD, antibody
This reagent is used for the detection of the Cw antigen (of the Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007406
In Commercial Distribution

  • 10888234000730 ()
0007406

  • Anti-C^w red blood cell grouping IVD, antibody
Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0007151
In Commercial Distribution

  • 10888234000723 ()
0007151

  • Anti-H red blood cell grouping IVD, lectin
GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007058
In Commercial Distribution

  • 10888234000716 ()
0007058

  • Bromelin immunohaematology reagent IVD
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration.
IMMUCOR, INC.
0006428
In Commercial Distribution

  • 10888234000600 ()
0006428

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
IMMUCOR, INC.
0006427
In Commercial Distribution

  • 10888234000594 ()
0006427

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
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